Principal Investigators are responsible for ensuring all applicable CITI training is current for their study team members. The IRB will only verify CITI training at the time of initial IRB submissions and when new study personnel are added.

OHRE has revised a number of SOPs to incorporate changes introduced with the implementation of the Revised Common Rule, as well as to reflect current practices and added several new SOPs. A summary of changes and links to the SOPs … Read more

All Subject Injury Language (SIL) in clinical trial informed consent forms has to be approved by the UNC Office of Clinical Trials? Questions about SIL or requests for SIL approval should go to sil@unc.edu

The UNC Scientific Review Committee and UNC IRB work closely together to ensure that studies at UNC demonstrate the highest possible quality of study design and human subjects protection.

UNC Healthcare staff are performing research billing reviews on ALL encounters related to any subject associated with a clinical trial in Epic. Linking study encounters in Epic speeds the process. Updating the subject status in CRMS or OnCore when the … Read more